FDA Application
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NDC Search Results on Active Ingredient: acetaminophen
Click on Active Ingredient to view the label.
Ingredient Name | NDC | Company Name | Application Number or Regulatory Citation | Product Type | Marketing Category |
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OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 35356-801-60 | Quality Care Products, LLC | ANDA202677 | HUMAN PRESCRIPTION DRUG | ANDA |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 35356-801-90 | Quality Care Products, LLC | ANDA202677 | HUMAN PRESCRIPTION DRUG | ANDA |
SALICYLAMIDE; ASPIRIN; ACETAMINOPHEN | 35418-242-02 | Zee Medical Inc | part343 | HUMAN OTC DRUG | OTC monograph not final |
SALICYLAMIDE; ASPIRIN; ACETAMINOPHEN | 35418-242-67 | Zee Medical Inc | part343 | HUMAN OTC DRUG | OTC monograph not final |
SALICYLAMIDE; ASPIRIN; ACETAMINOPHEN | 35418-242-68 | Zee Medical Inc | part343 | HUMAN OTC DRUG | OTC monograph not final |
SALICYLAMIDE; ASPIRIN; ACETAMINOPHEN | 35418-242-69 | Zee Medical Inc | part343 | HUMAN OTC DRUG | OTC monograph not final |
BUTALBITAL; ACETAMINOPHEN | 35573-455-02 | Burel Pharmaceuticals, LLC | ANDA214088 | HUMAN PRESCRIPTION DRUG | ANDA |
BUTALBITAL; ACETAMINOPHEN | 35573-456-02 | Burel Pharmaceuticals, LLC | ANDA214088 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN | 36000-306-60 | Baxter Healthcare Corporation | ANDA214331 | HUMAN PRESCRIPTION DRUG | ANDA |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN | 36800-035-06 | TOP CARE (Topco Associates LLC) | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 36800-036-06 | TOP CARE (Topco Associates LLC) | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 36800-095-03 | TopCo Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 36800-095-17 | TopCo Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 36800-096-91 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE | 36800-143-62 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE | 36800-143-73 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 36800-161-10 | Topco Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 36800-161-16 | Topco Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
CAFFEINE; PYRILAMINE MALEATE; ACETAMINOPHEN | 36800-187-24 | TOP CARE (Topco Associates LLC) | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 36800-202-00 | Topco Associates LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 36800-202-26 | Topco Associates LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 36800-202-28 | Topco Associates LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 36800-202-34 | Topco Associates LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 36800-228-01 | Topco Associates LLC | ANDA076200 | HUMAN OTC DRUG | ANDA |
ASPIRIN; CAFFEINE; ACETAMINOPHEN | 36800-243-10 | TOP CARE (Topco Associates LLC) | part343 | HUMAN OTC DRUG | OTC monograph not final |
CAFFEINE; ASPIRIN; ACETAMINOPHEN | 36800-246-60 | Topco Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 36800-250-56 | TopCare | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 36800-291-40 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE | 36800-297-04 | TOP CARE (Topco Associates LLC) | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 36800-298-02 | TOPCARE | part341 | HUMAN OTC DRUG | OTC monograph final |
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